946P - Ipilimumab and nivolumab in advanced hepatocellular carcinoma after failure of prior atezolizumab and bevacizumab treatment: A multicenter retrospective study

Background

The phase 3 CheckMate-9DW trial recently announced that ipilimumab plus nivolumab (Ipi/Nivo) significantly improved overall survival (OS) compared to sorafenib or lenvatinib, in advanced hepatocellular carcinoma (HCC). We evaluated the efficacy of Ipi/Nivo in patients with advanced HCC who had failed prior atezolizumab and bevacizumab (Ate/Bev) treatment.

Methods

Patients treated with Ipi/Nivo for advanced HCC from three referral hospitals were included. Patients received ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) every 3 weeks (four doses), followed by nivolumab (240 mg) every 2 weeks.

Results

Of 107 patients, we focused on immune-checkpoint inhibitor (ICI)-naïve (n=35) and Ate/Bev-experienced (n=49) groups. Baseline characteristics were as follows: median age of 60 years (range, 37-81); hepatitis B (n = 67, 79.8%); Child-Pugh A (n = 60, 71.8%); BCLC C (n = 73, 86.9%); macrovascular invasion (n = 32, 38.1%); extrahepatic metastasis (n = 68, 81.0%). Of the 78 evaluable patients, 4 achieved a complete response, and 16 achieved a partial response with an objective response rate (ORR) of 25.6%; ORR was 41.2% and 13.6% in ICI-naïve and Ate/Bev-experienced groups, respectively. Disease control rate was 38.5%, 58.8% and 22.7% in all, ICI-naïve, and Ate/Bev-experienced groups, respectively. With a median follow-up duration of 29.0 months (95% confidence interval [CI], 28.8-29.6), the median progression-free survival was 1.4 months (95%CI, 1.2-2.0) in all patients, 3.2 months (95%CI, 1.5-7.8) in ICI-naïve patients, and 1.3 months (95%CI, 1.1-1.4) in the Ate/Bev-experienced group (p = 0.006). Median overall survival was 5.8 months (95%CI, 3.9-8.1) in all patients, 9.3 months (95%CI, 4.1-not reached) in ICI-naïve, and 5.4 months in Ate/Bev-experienced group (p = 0.034). Multivariable analysis showed that thyroid dysfunction after Ipi/Nivo treatment was an independent prognostic factor for better PFS and OS.

Conclusions

Ipi/Nivo is a meaningful treatment option even after failure of Ate/Bev in patients with advanced HCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

H. Chon: Financial Interests, Personal, Invited Speaker: AstraZeneca, Bayer, Roche, AstraZeneca, Eisai, Bayer, BMS, Servier, Sanofi, Dong-A ST; Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, BeiGene, Eisai, Roche, Bayer, Ono, MSD, BMS, Sanofi, Servier, AstraZeneca, BeiGene. All other authors have declared no conflicts of interest.